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IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ribavirin (RBV)
BI 201335 (Faldaprevir)
Ribavirin (RBV)
BI 207127
BI 201335 (Faldaprevir)
Ribavirin (RBV)
BI 207127
Faldaprevir (BI 201335)
BI 207127
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following:

    1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or
    2. liver biopsy typical of chronic hepatitis C , or
    3. history of elevated ALT at least 6 months prior to screening.
  • HCV infection of sub-GT1b confirmed by genotypic testing at screening

  • Treatment naïve defined as:

    1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin and
    2. no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection
  • Plasma HCV RNA > or = 1,000 IU/mL at screening
  • Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.
  • Age 18 to 75 years

  • Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization

    1. with documented hysterectomy, or
    2. who have had both ovaries removed, or
    3. with documented tubal ligation, or
    4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
    5. of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms.

OR:

Male patients

  1. who are documented to be sterile, or
  2. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and
  3. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

Exclusion criteria:

  • HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  • HCV subtype 1a, mixed 1a/1b or GT1 undefined
  • Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease
  • HIV-1 or HIV-2 infection
  • Hepatitis B virus (HBV) infection based on presence of HBs-Ag
  • Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,
  • International Normalized Ratio (INR) > or =1.7
  • Serum albumin < 3.3 g/dL
  • Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease
  • Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
  • Patients with ongoing or historical photosensitivity or recurrent rash

Sites / Locations

  • 1241.20.00026 Boehringer Ingelheim Investigational Site
  • 1241.20.00033 Boehringer Ingelheim Investigational Site
  • 1241.20.00006 Boehringer Ingelheim Investigational Site
  • 1241.20.00003 Boehringer Ingelheim Investigational Site
  • 1241.20.00008 Boehringer Ingelheim Investigational Site
  • 1241.20.00015 Boehringer Ingelheim Investigational Site
  • 1241.20.00014 Boehringer Ingelheim Investigational Site
  • 1241.20.00004 Boehringer Ingelheim Investigational Site
  • 1241.20.00010 Boehringer Ingelheim Investigational Site
  • 1241.20.00001 Boehringer Ingelheim Investigational Site
  • 1241.20.00018 Boehringer Ingelheim Investigational Site
  • 1241.20.00002 Boehringer Ingelheim Investigational Site
  • 1241.20.00032 Boehringer Ingelheim Investigational Site
  • 1241.20.00009 Boehringer Ingelheim Investigational Site
  • 1241.20.00016 Boehringer Ingelheim Investigational Site
  • 1241.20.00031 Boehringer Ingelheim Investigational Site
  • 1241.20.00019 Boehringer Ingelheim Investigational Site
  • 1241.20.00024 Boehringer Ingelheim Investigational Site
  • 1241.20.00013 Boehringer Ingelheim Investigational Site
  • 1241.20.00005 Boehringer Ingelheim Investigational Site
  • 1241.20.00017 Boehringer Ingelheim Investigational Site
  • 1241.20.00012 Boehringer Ingelheim Investigational Site
  • 1241.20.00022 Boehringer Ingelheim Investigational Site
  • 1241.20.00020 Boehringer Ingelheim Investigational Site
  • 1241.20.43003 Boehringer Ingelheim Investigational Site
  • 1241.20.01001 Boehringer Ingelheim Investigational Site
  • 1241.20.01008 Boehringer Ingelheim Investigational Site
  • 1241.20.01010 Boehringer Ingelheim Investigational Site
  • 1241.20.01003 Boehringer Ingelheim Investigational Site
  • 1241.20.01006 Boehringer Ingelheim Investigational Site
  • 1241.20.01002 Boehringer Ingelheim Investigational Site
  • 1241.20.01005 Boehringer Ingelheim Investigational Site
  • 1241.20.01007 Boehringer Ingelheim Investigational Site
  • 1241.20.33003 Boehringer Ingelheim Investigational Site
  • 1241.20.33004 Boehringer Ingelheim Investigational Site
  • 1241.20.33006 Boehringer Ingelheim Investigational Site
  • 1241.20.33001 Boehringer Ingelheim Investigational Site
  • 1241.20.33005 Boehringer Ingelheim Investigational Site
  • 1241.20.33007 Boehringer Ingelheim Investigational Site
  • 1241.20.33002 Boehringer Ingelheim Investigational Site
  • 1241.20.33009 Boehringer Ingelheim Investigational Site
  • 1241.20.33008 Boehringer Ingelheim Investigational Site
  • 1241.20.49002 Boehringer Ingelheim Investigational Site
  • 1241.20.49004 Boehringer Ingelheim Investigational Site
  • 1241.20.49012 Boehringer Ingelheim Investigational Site
  • 1241.20.49001 Boehringer Ingelheim Investigational Site
  • 1241.20.49014 Boehringer Ingelheim Investigational Site
  • 1241.20.49009 Boehringer Ingelheim Investigational Site
  • 1241.20.49008 Boehringer Ingelheim Investigational Site
  • 1241.20.49013 Boehringer Ingelheim Investigational Site
  • 1241.20.49011 Boehringer Ingelheim Investigational Site
  • 1241.20.49006 Boehringer Ingelheim Investigational Site
  • 1241.20.49003 Boehringer Ingelheim Investigational Site
  • 1241.20.49010 Boehringer Ingelheim Investigational Site
  • 1241.20.49005 Boehringer Ingelheim Investigational Site
  • 1241.20.49007 Boehringer Ingelheim Investigational Site
  • 1241.20.36001 Boehringer Ingelheim Investigational Site
  • 1241.20.36002 Boehringer Ingelheim Investigational Site
  • 1241.20.35303 Boehringer Ingelheim Investigational Site
  • 1241.20.35301 Boehringer Ingelheim Investigational Site
  • 1241.20.35302 Boehringer Ingelheim Investigational Site
  • 1241.20.39007 Boehringer Ingelheim Investigational Site
  • 1241.20.39003 Boehringer Ingelheim Investigational Site
  • 1241.20.39002 Boehringer Ingelheim Investigational Site
  • 1241.20.39008 Boehringer Ingelheim Investigational Site
  • 1241.20.39006 Boehringer Ingelheim Investigational Site
  • 1241.20.39005 Boehringer Ingelheim Investigational Site
  • 1241.20.39001 Boehringer Ingelheim Investigational Site
  • 1241.20.39004 Boehringer Ingelheim Investigational Site
  • 1241.20.31001 Boehringer Ingelheim Investigational Site
  • 1241.20.31003 Boehringer Ingelheim Investigational Site
  • 1241.20.31004 Boehringer Ingelheim Investigational Site
  • 1241.20.31006 Boehringer Ingelheim Investigational Site
  • 1241.20.31005 Boehringer Ingelheim Investigational Site
  • 1241.20.35103 Boehringer Ingelheim Investigational Site
  • 1241.20.35104 Boehringer Ingelheim Investigational Site
  • 1241.20.35101 Boehringer Ingelheim Investigational Site
  • 1241.20.35102 Boehringer Ingelheim Investigational Site
  • 1241.20.35105 Boehringer Ingelheim Investigational Site
  • 1241.20.40001 Boehringer Ingelheim Investigational Site
  • 1241.20.40002 Boehringer Ingelheim Investigational Site
  • 1241.20.40003 Boehringer Ingelheim Investigational Site
  • 1241.20.70002 Boehringer Ingelheim Investigational Site
  • 1241.20.70001 Boehringer Ingelheim Investigational Site
  • 1241.20.70004 Boehringer Ingelheim Investigational Site
  • 1241.20.70005 Boehringer Ingelheim Investigational Site
  • 1241.20.34007 Boehringer Ingelheim Investigational Site
  • 1241.20.34004 Boehringer Ingelheim Investigational Site
  • 1241.20.34002 Boehringer Ingelheim Investigational Site
  • 1241.20.34005 Boehringer Ingelheim Investigational Site
  • 1241.20.34003 Boehringer Ingelheim Investigational Site
  • 1241.20.34001 Boehringer Ingelheim Investigational Site
  • 1241.20.34008 Boehringer Ingelheim Investigational Site
  • 1241.20.34006 Boehringer Ingelheim Investigational Site
  • 1241.20.44005 Boehringer Ingelheim Investigational Site
  • 1241.20.44007 Boehringer Ingelheim Investigational Site
  • 1241.20.44001 Boehringer Ingelheim Investigational Site
  • 1241.20.44002 Boehringer Ingelheim Investigational Site
  • 1241.20.44006 Boehringer Ingelheim Investigational Site
  • 1241.20.44004 Boehringer Ingelheim Investigational Site
  • 1241.20.44003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Allocated 24 weeks BI 207127 + BI 201335

Randomized 16 weeks BI 7127+BI1335 + RBV

Randomized 24weeks BI 7127+ BI1335 + RBV

Arm Description

24 weeks of BI 207127 and BI 201335 in combination with Ribavirin

16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV

24 weeks of BI 207127and BI 201335 in combination with RBV

Outcomes

Primary Outcome Measures

SVR12 Rates With Historical Control
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Comparisons of SVR12 Rates Across Treatment Arms
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

Secondary Outcome Measures

SVR4
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
SVR24
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).

Full Information

First Posted
November 6, 2012
Last Updated
March 17, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01732796
Brief Title
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Official Title
A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allocated 24 weeks BI 207127 + BI 201335
Arm Type
Experimental
Arm Description
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Arm Title
Randomized 16 weeks BI 7127+BI1335 + RBV
Arm Type
Experimental
Arm Description
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Arm Title
Randomized 24weeks BI 7127+ BI1335 + RBV
Arm Type
Experimental
Arm Description
24 weeks of BI 207127and BI 201335 in combination with RBV
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
24 weeks of active RBV
Intervention Type
Drug
Intervention Name(s)
BI 201335 (Faldaprevir)
Intervention Description
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
24 weeks of active RBV
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
24 weeks of BI 207127
Intervention Type
Drug
Intervention Name(s)
BI 201335 (Faldaprevir)
Intervention Description
24 weeks of BI 201335
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
Intervention Type
Drug
Intervention Name(s)
Faldaprevir (BI 201335)
Intervention Description
24 weeks of 201335
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
24 weeks of BI 207127
Primary Outcome Measure Information:
Title
SVR12 Rates With Historical Control
Description
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Time Frame
12 Week (post-treatment)
Title
Comparisons of SVR12 Rates Across Treatment Arms
Description
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Time Frame
12 Week (post-treatment)
Secondary Outcome Measure Information:
Title
SVR4
Description
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
Time Frame
4 Week (post-treatment)
Title
SVR24
Description
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
Time Frame
24 Week (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at screening in addition to at least one of the following: positive HCV RNA or HCV antibodies at least 6 months prior to screening, or liver biopsy typical of chronic hepatitis C , or history of elevated ALT at least 6 months prior to screening. HCV infection of sub-GT1b confirmed by genotypic testing at screening Treatment naïve defined as: no prior treatment with any interferon, pegylated interferon, and /or ribavirin and no prior treatment with at least one dose of any other licensed or investigational antiviral agent for acute or chronic hepatitis C infection Plasma HCV RNA > or = 1,000 IU/mL at screening Liver biopsy within three years or fibroscan within six months prior to randomization. Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included. Age 18 to 75 years Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization with documented hysterectomy, or who have had both ovaries removed, or with documented tubal ligation, or who are post-menopausal with last menstrual period at least 12 months prior to screening, or of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are diaphragm with spermicide substance, intrauterine devices, cervical caps and condoms. OR: Male patients who are documented to be sterile, or who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, and without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor). Exclusion criteria: HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. HCV subtype 1a, mixed 1a/1b or GT1 undefined Evidence of liver disease mainly due to causes other than chronic HCV infection such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease HIV-1 or HIV-2 infection Hepatitis B virus (HBV) infection based on presence of HBs-Ag Evidence of decompensated liver disease, or history of decompensated liver disease, defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices, International Normalized Ratio (INR) > or =1.7 Serum albumin < 3.3 g/dL Serum total bilirubin >2.0 times the upper limit of normal (ULN) with direct/indirect ratio >1, unless history of Gilbert's disease Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) Patients with ongoing or historical photosensitivity or recurrent rash
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1241.20.00026 Boehringer Ingelheim Investigational Site
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
1241.20.00033 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1241.20.00006 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1241.20.00003 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
1241.20.00008 Boehringer Ingelheim Investigational Site
City
Poway
State/Province
California
Country
United States
Facility Name
1241.20.00015 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1241.20.00014 Boehringer Ingelheim Investigational Site
City
Fort Pierce
State/Province
Florida
Country
United States
Facility Name
1241.20.00004 Boehringer Ingelheim Investigational Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
1241.20.00010 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1241.20.00001 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1241.20.00018 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1241.20.00002 Boehringer Ingelheim Investigational Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
1241.20.00032 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
1241.20.00009 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1241.20.00016 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1241.20.00031 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1241.20.00019 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
1241.20.00024 Boehringer Ingelheim Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
1241.20.00013 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1241.20.00005 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1241.20.00017 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1241.20.00012 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1241.20.00022 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1241.20.00020 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1241.20.43003 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
1241.20.01001 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.20.01008 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.20.01010 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.20.01003 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1241.20.01006 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1241.20.01002 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1241.20.01005 Boehringer Ingelheim Investigational Site
City
Whitby
State/Province
Ontario
Country
Canada
Facility Name
1241.20.01007 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1241.20.33003 Boehringer Ingelheim Investigational Site
City
Clermont-Ferrand Cedex
Country
France
Facility Name
1241.20.33004 Boehringer Ingelheim Investigational Site
City
Lyon
Country
France
Facility Name
1241.20.33006 Boehringer Ingelheim Investigational Site
City
Marseille Cedex 08
Country
France
Facility Name
1241.20.33001 Boehringer Ingelheim Investigational Site
City
Montpellier Cedex 5
Country
France
Facility Name
1241.20.33005 Boehringer Ingelheim Investigational Site
City
Nice Cedex 3
Country
France
Facility Name
1241.20.33007 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1241.20.33002 Boehringer Ingelheim Investigational Site
City
Pessac Cedex
Country
France
Facility Name
1241.20.33009 Boehringer Ingelheim Investigational Site
City
Rennes Cedex 09
Country
France
Facility Name
1241.20.33008 Boehringer Ingelheim Investigational Site
City
Vandoeuvre Cedex
Country
France
Facility Name
1241.20.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.20.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.20.49012 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1241.20.49001 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1241.20.49014 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1241.20.49009 Boehringer Ingelheim Investigational Site
City
Herne
Country
Germany
Facility Name
1241.20.49008 Boehringer Ingelheim Investigational Site
City
Kiel
Country
Germany
Facility Name
1241.20.49013 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1241.20.49011 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1241.20.49006 Boehringer Ingelheim Investigational Site
City
Magdeburg
Country
Germany
Facility Name
1241.20.49003 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1241.20.49010 Boehringer Ingelheim Investigational Site
City
Oberhausen
Country
Germany
Facility Name
1241.20.49005 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
Facility Name
1241.20.49007 Boehringer Ingelheim Investigational Site
City
Würzburg
Country
Germany
Facility Name
1241.20.36001 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1241.20.36002 Boehringer Ingelheim Investigational Site
City
Kaposvar
Country
Hungary
Facility Name
1241.20.35303 Boehringer Ingelheim Investigational Site
City
Dublin 8
Country
Ireland
Facility Name
1241.20.35301 Boehringer Ingelheim Investigational Site
City
Dublin
Country
Ireland
Facility Name
1241.20.35302 Boehringer Ingelheim Investigational Site
City
Dublin
Country
Ireland
Facility Name
1241.20.39007 Boehringer Ingelheim Investigational Site
City
Ancona
Country
Italy
Facility Name
1241.20.39003 Boehringer Ingelheim Investigational Site
City
Brescia
Country
Italy
Facility Name
1241.20.39002 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1241.20.39008 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1241.20.39006 Boehringer Ingelheim Investigational Site
City
Napoli
Country
Italy
Facility Name
1241.20.39005 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1241.20.39001 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1241.20.39004 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1241.20.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1241.20.31003 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1241.20.31004 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1241.20.31006 Boehringer Ingelheim Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
1241.20.31005 Boehringer Ingelheim Investigational Site
City
Groningen
Country
Netherlands
Facility Name
1241.20.35103 Boehringer Ingelheim Investigational Site
City
Aveiro
Country
Portugal
Facility Name
1241.20.35104 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1241.20.35101 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1241.20.35102 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
1241.20.35105 Boehringer Ingelheim Investigational Site
City
Vila Real
Country
Portugal
Facility Name
1241.20.40001 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.20.40002 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.20.40003 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.20.70002 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1241.20.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1241.20.70004 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1241.20.70005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1241.20.34007 Boehringer Ingelheim Investigational Site
City
A Coruña
Country
Spain
Facility Name
1241.20.34004 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1241.20.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.20.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.20.34003 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1241.20.34001 Boehringer Ingelheim Investigational Site
City
Majadahonda, Madrid
Country
Spain
Facility Name
1241.20.34008 Boehringer Ingelheim Investigational Site
City
Santander
Country
Spain
Facility Name
1241.20.34006 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1241.20.44005 Boehringer Ingelheim Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
1241.20.44007 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
1241.20.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1241.20.44002 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1241.20.44006 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1241.20.44004 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
1241.20.44003 Boehringer Ingelheim Investigational Site
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27920566
Citation
Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related links

Learn more about this trial

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

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